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Metabolic Effects of Switching Kaletra to Boosted Reyataz

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00413153
First Posted: December 19, 2006
Last Update Posted: March 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by:
Massachusetts General Hospital
Results First Submitted: November 4, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: atazanavir/ritonavir
Drug: lopinavir/ritonavir

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Boosted Reyataz (ATV/r) Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
Continue Kaletra (LPV/r) Kaletra (pre-study dose)
Total Total of all reporting groups

Baseline Measures
   Boosted Reyataz (ATV/r)   Continue Kaletra (LPV/r)   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   8   15 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   7   8   15 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 46  (8)   50  (6)   48  (7) 
Gender 
[Units: Participants]
     
Female   2   1   3 
Male   5   7   12 
Region of Enrollment 
[Units: Participants]
     
United States   7   8   15 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Glucose Trafficking   [ Time Frame: 6 months ]

2.  Secondary:   Insulin Sensitivity   [ Time Frame: 6 months ]

3.  Secondary:   Fasting Glucose   [ Time Frame: 6 months ]

4.  Secondary:   Lipid Metabolism - Serum Triglyceride   [ Time Frame: 6 months ]

5.  Secondary:   Body Composition - Visceral Adipose Tissue   [ Time Frame: 6 months ]

6.  Secondary:   Immune Parameters -- CD4 Count   [ Time Frame: 6 months ]

7.  Secondary:   Liver Enzymes -- Aspartate Aminotransferase (AST)   [ Time Frame: 6 months ]

8.  Secondary:   Liver Enzymes -- Alanine Aminotransferase (ALT)   [ Time Frame: 6 months ]

9.  Secondary:   Total Bilirubin   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information